ALTEN
Engineering • IT Services • Aerospace
ALTEN is a leader in outsourced Engineering and R&D and IT Services, catering to various industries such as aeronautics, automotive, banking, and life sciences. With a workforce of over 57,400 employees across nearly 30 countries, ALTEN specializes in executing complex and technical projects, supporting innovation and technology advancements in multiple sectors. The company focuses on providing engineering services, project management, and IT solutions to enhance client operations and foster sustainable innovation.
10,000+ employees
🚀 Aerospace
Regulatory Affairs Specialist
Job not on LinkedIn
November 8
🗣️🇩🇪 German Required
ALTEN
Engineering • IT Services • Aerospace
ALTEN is a leader in outsourced Engineering and R&D and IT Services, catering to various industries such as aeronautics, automotive, banking, and life sciences. With a workforce of over 57,400 employees across nearly 30 countries, ALTEN specializes in executing complex and technical projects, supporting innovation and technology advancements in multiple sectors. The company focuses on providing engineering services, project management, and IT solutions to enhance client operations and foster sustainable innovation.
10,000+ employees
🚀 Aerospace
📋 Description
• prepare, maintain and submit regulatory applications (eCTD, IMPD, CTA, variations, renewals) • take responsibility for lifecycle management of medicinal products or medical devices • review and approve labeling, packaging materials and product information • work closely with regulatory authorities, notified bodies and internal departments (QA, R&D, Clinical) • support audits, inspections and compliance activities • ensure compliance with regulatory requirements (EU MDR, IVDR, GMP, ISO 13485, ICH guidelines) • contribute to process optimizations and the digitization of regulatory workflows
🎯 Requirements
• degree in pharmacy or a comparable scientific discipline • at least three years' professional experience in regulatory affairs (pharmaceutical, biotech or medtech) • confident handling of regulatory procedures, dossiers and regulatory systems (e.g., eCTD, TrackWise, Veeva) • solid knowledge of relevant regulations (EU MDR, IVDR, ICH, GMP, GxP) • team-oriented, goal-driven and highly committed • business-fluent German and English, both written and spoken
🏖️ Benefits
• Talent management – we develop your career • Work–life balance – flexible working hours and mobile/home working options • Fit and relaxed – with EGYM Wellpass • Enjoy biking – company bike leasing • Green mobility – discounted mobility options • permanent employment contract • Corporate Benefits • Team events
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